Hydrotherapy in Duchenne Muscular Dystrophy (DMD)

Duchenne Muscular Dystrophy Clinical Trial

Official title:

Hydrotherapy for Health in Boys and Adolescents With Duchenne Muscular Dystrophy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06445985
• Other study ID #: 304633
• Secondary ID: 21/PR/1748
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2022
• Est. completion date: December 12, 2025

Study information

• Verified date: May 2024
• Source: Lancashire Teaching Hospitals NHS Foundation Trust
• Contact: Kina Dr Bennett
• Phone: 441772522031
• Email: kina.bennett[@]lthtr.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial aims to establish if there are meaningful benefits to providing a hydrotherapy service for young people with Duchenne muscular dystrophy (DMD). The main aims are to: 1. to allocate a clinical physiotherapist to a project implementing hydrotherapy in young patients with DMD to establish whether there are meaningful benefits to their daily life. 2. to conduct patient and parent interviews to understand the barriers to completing a hydrotherapy intervention and ensure future research addresses meaningful outcomes for those with DMD.

Description:

The quality of life in young males with Duchenne muscular dystrophy (DMD) is negatively impacted by daily pain, changes in body composition and a lack of support to undertake physical activity. Hydrotherapy represents a potential means of involving boys and adolescents with DMD in activity that could benefit the negative factors influencing their quality of life. There are presently no guidelines or evidence for the benefits of hydrotherapy with the standards of care for young males with DMD.

This trial will provide evidence that will allow care providers to advocate the use of hydrotherapy within the management of DMD, as an inclusive activity, that can be adopted by those with DMD who are either ambulatory, or non-ambulatory. Through 12-weeks of hydrotherapy, the trial will investigate whether there are benefits to physical function, pain and quality of life. These measures represent meaningful outcomes in the progression of DMD, and have direct patient impact for those affected by DMD. On completion of the hydrotherapy, there will be a series of interviews with some of the participants and their parents. The aim of these interviews is to understand participant and parent barriers to hydrotherapy, and uncover whether hydrotherapy improves the lives of the participants beyond simple clinical measures and questionnaires.

The study aims recruit 44 boys and young men with Duchenne muscular dystrophy. Patients will be recruited from NHS neuromuscular services and through families who attend the local hospice.

Following an informed consent process they will enter the first 12 week stage, as a control to observe and measure their habitual physical activity, along with monitoring their diet. They will then enter the intervention stage where they will have a weekly physiotherapy led pool session with a number of physical activities. During the hydrotherapy period, participants will access the hydrotherapy pool once a week for 12 weeks. Sessions are supervised by an experienced physiotherapist, who will guide the exercise for a session lasting 30 to 60 minutes.

The exercises, intensity and specific hydrotherapy plan will be derived from consultation with the participants and their parents. Due to the variance within the presentation of the condition, and the inclusive age range within the study, an externally valid approach to exercise prescription will be utilised. Diet and physical function will be measured during this stage.

There will be a number of assessments to be completed at 3 time points. As much as possible these will be arranged as single visits. The first before the control period, the second after the control period, and the third after the hydrotherapy period. The assessments include a number of physical assessments, including assessments of function and ability, body mass and quality of life. After completion, all participants will be invited to complete a qualitative interview, in particular enquiring about the experience and logistics of hydrotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 12, 2025
• Est. primary completion date: December 12, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Years to 25 Years

Eligibility

Inclusion Criteria:

• Established diagnosis of Duchenne Muscular Dystrophy (either by genetics or muscle biopsy)

• Between 6 and 25 years of age

• On stable dose of steroids or not on steroids

Exclusion Criteria:

• Younger than 6 years, older than 25 years

• Recent change in steroid dose, less than 3 months prior

• Undertaking formal hydrotherapy supervised by physiotherapist on a regular basis (weekly or more frequent)

Related Conditions & MeSH terms

• Duchenne Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne

Intervention

Other:
• Hydrotherapy
Physiotherapy led pool session

Locations

Country	Name	City	State
United Kingdom	Lancashire Teaching Hospitals NHS Foundation Trust	Preston	Lancashire

Sponsors (2)

Lead Sponsor	Collaborator
Lancashire Teaching Hospitals NHS Foundation Trust	Duchenne UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass via Bioelectrical impedance (BIA)	Fat mass, body fat percentage and fat free mass will be measured using BIA (bioelectrical impedance). BIA has been validated in DMD and is accurate enough to measure longitudinal changes in body composition and muscle mass in this population	24 weeks
Primary	Pain Scale	A pain map assessment of the topographic distribution of daily pain will also be competed, consistent with our previous work in DMD. Scale of 1-10	24 weeks
Primary	PedsQL QoL / DMD QoL - Quality of Life	PedsQL QoL - Quality of Life for both participants, and the DMD-QoL Proxy for parents - Scale of 0-4	24 weeks
Secondary	Upper Limb Strength	Upper limb strength using grip and pinch measure using digital, handheld dynamometers North-Star	24 weeks
Secondary	Range of Motion	Limited ankle range of motion (ROM) Ankle plantarflexion-dorsiflexion (PF-DF ROM) will be assessed through a goniometer	24 weeks
Secondary	Pulmonary function	Pulmonary function will be assessed using digital spirometry	24 weeks